Associate Director, Formulation Development

This is a fully remote position, open to applicants in California, +2 more states.

📋 Description

• Manage all facets of the drug product development program from candidate selection through to clinical stages.

• Execute pre-formulation studies, which include API form characterization and selection, in collaboration with Process Chemistry.

• Design, implement, and analyze formulation screening and excipient selection studies.

• Establish phase-appropriate formulation strategies that balance clinical requirements, manufacturability, regulatory expectations, and commercial factors.

• Create robust, scalable, and cost-effective manufacturing processes for drug products.

• Oversee drug product process development, technology transfer, and manufacturing initiatives at external CDMOs.

• Evaluate and authorize process development protocols, master batch records, manufacturing campaign reports, executed batch records, quality investigations, and batch disposition records.

• Provide on-site support for manufacturing campaigns as necessary.

• Aid in defining critical quality attributes and critical process parameters.

• Write or review development reports and risk assessments.

• Draft assigned CMC sections for IND, IMPD, NDA, and MAA submissions, and respond to inquiries from regulatory bodies.

• Act as the subject matter expert in drug products for cross-functional teams.

• Collaborate with CMC and the broader development team to ensure the delivery of high-quality drug products for clinical trials.

• Maintain expertise in formulation and process development.

• Adhere to cGMP, safety, and regulatory standards.

• Report directly to the Head of CMC.

⛳️ Requirements

• PhD in pharmaceutics, pharmaceutical sciences, chemical engineering, chemistry, or a related field with over 8 years of industry experience; or MS or BS in a relevant field with over 12 years of industry experience.

• Fundamental understanding of pre-formulation studies, formulation design and development, and drug product manufacturing process development.

• Experience in developing formulations for poorly soluble BCS Class II/IV compounds.

• Background in drug product technology transfer and manufacturing processes.

• Experience in managing CDMOs for research, development, and manufacturing initiatives.

• Strong knowledge of FDA, EMA, and ICH regulatory guidelines.

• Ability to translate regulatory guidance into practical solutions and development strategies.

• Outstanding decision-making abilities and capacity to work independently in a dynamic, high-pressure environment.

• Excellent technical writing skills, particularly for regulatory submissions and responses to regulatory inquiries.

• Commitment to values-based leadership, integrity, and ethics in pharmaceutical product development and manufacturing.

• Preferred: Experience in dry/wet granulation, extrusion, spray drying, tableting, and coating processes.

• Preferred: Familiarity with physicochemical and biopharmaceutical properties related to formulation design.

• Preferred: Knowledge of QbD, QTPP, CQA, CMA, CPP, FMEA, and risk assessment methodologies.

• Preferred: Experience in pediatric formulation development.

• Preferred: Proficiency in HPLC, LC-MS, XRPD, DSC, dissolution, and KF techniques.

• Preferred: Experience with IND/IMPD and NDA/MAA submissions.

• Preferred: Experience in managing quality investigations.

🏝️ Benefits

• Opportunity for remote work.

• Travel requirements: 10 to 20%.

• Inclusive, collaborative, and mission-driven workplace culture.

• Commitment to equal opportunity employment.